Validation Online Blog.

Mar 11, Site Stats.

Thu, 11 Mar 2010 10:53:48 GMT

Site Stats,

Mar 10, Combined IQ-OQ Protocol.

Wed, 10 Mar 2010 15:17:21 GMT

Combined IQ-OQ. Put this equipmentvalidation protocol into use within minutes of downloading it. Fully detailed & interacive (bespoke or embedded software) Fast to use and highly cost effective.

Mar 9, Validation Online.

Tue, 09 Mar 2010 12:19:03 GMT

Validation Online for FDA and GMP requirements in the USA & Associated Markets. Iinteractive Documents that are compliant with USA (FDA), EU, MHRA, WHO, and cGXP

Mar 9, Computer Validation (CV).

Tue, 09 Mar 2010 12:04:08 GMT

Computer Validation (CV) - FDA and GMP requirements for the USA & Associated Markets. GMP Documents from the VMP via the DQ, VRA, IQ & OQ to the PQ.

Mar 8, Validation Master Plan (VMP).

Mon, 08 Mar 2010 11:58:29 GMT

Validation Master Plan (VMP). FDA and GMP requirements in the USA & Associated Markets. Fast cost effective documentation, compliant with USA (FDA), EU (MHRA) and cGXP requirements worldwide.

Mar 8, User Requirements Specification. (URS)

Mon, 08 Mar 2010 11:55:48 GMT

User Requirements Specification (URS) FDA and GMP requirements in the USA & Associated Markets, Compliant with USA (FDA), EU (MHRA) and cGXP requirements worldwide.

Mar 8, Operational Qualification (OQ)

Mon, 08 Mar 2010 11:42:37 GMT

Operational Qualification (OQ). SOP for FDA and GMP requirements in Validation. Cost effective documentation, compliant with USA (FDA), EU, MHRA, WHO, and cGXP requirements worldwide.

Mar 8, Installation Qualification.

Mon, 08 Mar 2010 11:34:12 GMT

Installation qualification. FDA and GMP requirements in the USA & Associated Markets.Documents from the URS to the PQ.

Feb 28, Autoclave Validation Documentation.

Sun, 28 Feb 2010 17:45:20 GMT

Autoclave Validation. GMP & regulatory compliant protocols from the URS to the PQ via the VP, DQ, VRA, IQ and OQ. Templates and Bespoke ready to us documents for the Bio-Medical industries.

Feb 24, Validation Risk Assessment (VRA).

Wed, 24 Feb 2010 15:30:19 GMT

Validation Risk Assessment (VRA) Scope.

Feb 20, Agency Reviewed Documents

Sat, 20 Feb 2010 17:37:31 GMT

Agency Reviewed Documents. A valuable second income for the validation professional. FDA vompliant documentation.

Feb 17, Blocked Ear Wax

Wed, 17 Feb 2010 14:09:31 GMT

Blocked Ear Wax requires Ear Wax Gone to painlessly, hygenically and swiftly remove the blocking ear wax.

Feb 16, Humidity Calibration & Hygrometer Sensor Calibration

Tue, 16 Feb 2010 11:35:57 GMT

Humidity Calibration & Hygrometer Sensor Calibration. FDA , MHRA, EC and WHO compliant documentation and materials for the calibration of moisture measurement. instruments

Feb 15, Shop

Mon, 15 Feb 2010 14:26:01 GMT

Shop

Feb 13, EAR WAX REMOVAL.

Sat, 13 Feb 2010 10:09:16 GMT

Ear Wax Gone, Painless and Quick Ear Wax Removal.

Feb 11, Standard Operating Procedure (SOP)

Thu, 11 Feb 2010 10:08:03 GMT

Standard Operating Procedure for writing a Standard Operating Procedure. A mandatory GMP requirement/

Feb 11, Design Qualification (DQ)

Thu, 11 Feb 2010 09:55:17 GMT

Design Qualification (DQ) - Validation Online for FDA and GMP requirements in the USA & Associated Markets - Uniquely Interactive and Highly Cost Effective Documents.

Jan 29, Good Manufacturing Practice (GMP).

Fri, 29 Jan 2010 11:40:24 GMT

Good Manufacturing Practice (GMP) are mandated by the FDA, MHRA, WHO and in general by worldwide Bio-Med regulatory agencies.

Jan 27, Validation Online Blog.

Wed, 27 Jan 2010 13:50:11 GMT

Validation Online's site for cost effective documentation, compliant with USA (FDA), EU (MHRA) and cGXP requirements worldwide.

Jan 7, Regulatory Authorities

Thu, 07 Jan 2010 12:58:39 GMT

Regulatory Authorities World Wide.

Dec 17, Validation Requirements.

Thu, 17 Dec 2009 11:31:58 GMT

Validation Requirements.

Dec 15, Asperger Syndrome.

Tue, 15 Dec 2009 09:44:01 GMT

Asperger Syndrome.

Dec 15, asperger

Tue, 15 Dec 2009 09:43:07 GMT

Asperger Syndrome.

Dec 3, Vendor Audit.

Thu, 03 Dec 2009 10:34:18 GMT

Scope of Vendor Audit. Fast Cost Effective Documents.

Nov 28, LAN Validation.

Sat, 28 Nov 2009 17:34:46 GMT

LAN Validation. Local Area Network Validation.

Nov 27, Humidity and Hygrometer Calibration

Fri, 27 Nov 2009 15:21:57 GMT

Humidity sensors require frequent calibration and continual monitoring, they are, along with pH sensors, the most prone to error sensors in general facility use. Where as most sensors measure to within (plus or minus) 1 and have extremely low drift rates. Most competitively priced humidity sensors measure to within (plus or minus) 3 at mid range and 5-7 at the top and bottom of their ranges, and have a significant drift rate. Where the humidity is controlled to protect a regulated product it is essential that your humidity sensor is not allowed to drift out of calibration. Calibration periodicity should therefore start at 4/6 months and be extended as youre calibration history (trend analysis) establishes a justification for extending this period between calibrations. Where the humidity is controlled for creature and equipment comfort and protection, it is false economy to not calibrate frequently. These sensors do drift, and if in the AHU (air handling unit) this occurs, then the air will be over chilled, as the AHU attempts to remove an erroneous amount of moisture from the air. This over-chilled air has then to be reheated for room use. This can be extremely severe and add very considerable costs to the annual energy bill for each AHU. Calibration Methods. The normal cost of test equipment for the calibration of humidity sensors is around $10K. This precludes most companies from setting up in-house calibration. Subsequently this calibration is usually performed by an external calibration company. However there are alternative calibration methods. We have used certified saturated salts solutions for nearly twenty years and they are very reliable and, just like the column of water or mercury, they are basic standards. The only variable is temperature. So with your saturated solution and a temperature gauge you can calibrate any humidity sensor or hygrometer. VAISALA news No humidity instrument stays accurate on its own. From time to time, the performance of these instruments must be checked against a reference. When calibration is done in-house, the use of saturated salt solutions as a reference is a proven and affordable method. National Physical Laboratory (NPL) Saturated (or unsaturated) salt solutions, and certain other chemicals, can be used to generate an environment of a particular relative humidity in an enclosure. Saturated salt solutions, with solid salt present, have the special property that a stable concentration is maintained - and hence a constant relative humidity - even if water migrates to or from the solution. OMEGA Process and Measurement Control. Saturated Salt Solutions: A very convenient method to calibrate humidity sensors is the use of saturated salt solutions. At any temperature, the concentration of a saturated solution is fixed and does not have to be determined. For further details regarding our Humidity and Hygrometer Calibration Kits Click Here.

Nov 26, Validation Manual

Thu, 26 Nov 2009 14:58:01 GMT

Validation Manual, Uniquely interactive and highly cost effective documents.

Nov 18, FDA Warning Letters and Comments.

Wed, 18 Nov 2009 18:32:25 GMT

FDA Warning Letters and Comments. Uniquely interactive and highly cost effective documents.

Nov 18, SOP for cGMP Review

Wed, 18 Nov 2009 13:40:38 GMT

SOP for cGMP Review. Uniquely Interactive and Highly Cost Effective Documents for FDA and GMP requirements in the USA & Associated Markets.

Nov 18, HVAC Qualification Documents

Wed, 18 Nov 2009 13:27:08 GMT

HVAC Qualification Documents. FDA and GMP requirements in the USA & Associated Markets

Nov 18, FMEA.

Wed, 18 Nov 2009 13:24:28 GMT

FMEA for Bio-Med Risk Analysis. FDA and GMP Requirements in the USA & Associated Markets, VMP, DQ, VRA, IQ, OQ & PQ Available.

Nov 18, Facilities Qualification

Wed, 18 Nov 2009 13:19:35 GMT

Facilities Qualification. FDA and GMP requirements in the USA & Associated Markets. Fast Cost Effective Documentation.

Nov 11, Performance Qualification (P1Q)

Wed, 11 Nov 2009 17:02:31 GMT

Performance Qualification (P1Q) Scope.

Nov 9, Hardware Validation.

Mon, 09 Nov 2009 14:06:42 GMT

Hardware Validation.

Nov 5, Medical Device Reporting.

Thu, 05 Nov 2009 16:28:17 GMT

The FDAs Center for Devices and Radiological Health (CDRH) published a notice of draft guidance that will require all medical device adverse event reports to be submitted electronically. While the process of electronic submission of data is a more efficient and traceable means for reporting, it could prove to be a very long and challenging road for the average medical device manufacturer to transition from its current paper-based reporting process to an electronic reporting process.

ARE YOU READY FOR THIS?

Nov 3, Unique Problem.

Tue, 03 Nov 2009 14:38:26 GMT

Unique Problem

Nov 3, Unique Process or Idea.

Tue, 03 Nov 2009 14:37:36 GMT

Unique Process or Idea.

Nov 1, Part 11.

Sun, 01 Nov 2009 16:46:26 GMT

Part 11. Validation Online's site for cost effective documentation, compliant with USA (FDA), EU (MHRA) and cGXP requirements worldwide.

Nov 1, Validation-Protocols

Sun, 01 Nov 2009 16:18:44 GMT

Validation-Protocols

Nov 1, Validation Plan.

Sun, 01 Nov 2009 16:15:24 GMT

Validation Plan an Introduction.

Nov 1, Validation Documentation an Introduction. Validation Protocols & GMP Documents.

Sun, 01 Nov 2009 16:07:01 GMT

Validation Documentation an Introduction.

Nov 1, Validation Documentation Matrix.

Sun, 01 Nov 2009 16:05:47 GMT

Validation Documentation Matrix.

Nov 1, Temperature Mapping Techniques.

Sun, 01 Nov 2009 16:01:02 GMT

Temperature Mapping

Nov 1, Steam Quality Testing

Sun, 01 Nov 2009 15:58:23 GMT

Steam Quality Testing. Fast Interactive Cost Effective Documentation.

Nov 1, Standard Operating Practice (SOP)

Sun, 01 Nov 2009 15:53:20 GMT

Standard Operating Practice for Writing SOP's for the Pharmaceutical Industries.

Nov 1, Special Operating Procedure.

Sun, 01 Nov 2009 15:52:27 GMT

Special Operating Procedure's in the Pharmaceutical Industries.

Nov 1, RISK INTERPRETATION IN VALIDATION

Sun, 01 Nov 2009 15:48:24 GMT

RISK INTERPRETATION IN VALIDATION

Nov 1, RISK BASED VALIDATION.

Sun, 01 Nov 2009 15:47:33 GMT

RISK BASED VALIDATION.

Nov 1, PREDICATE RULES.

Sun, 01 Nov 2009 15:42:41 GMT

PREDICATE RULES. A simple easy to use compendium of cGMP predicate rules.

Nov 1, Pharmaceutical Validation.

Sun, 01 Nov 2009 15:40:47 GMT

Pharmaceutical Validation. Free download SOP for Validation. Interactive protocol templates or bespoke validation documentation from VMP through VMP, URS, DQ, IQ, OQ, to PQ. vmp,